Drug product
ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET
D-0539-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55 Boxes
- Official record key
drug-enforcement:D-0539-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 12699501
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations